NCT01336933 · OUTCOME

To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events

Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma · Source last updated 2023-09-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: 22 months

What was measured

Adverse events will be summarized using patient level incidence rates so that a patient contributes once to any adverse event. The number and percentage of patients with any adverse event will be summarized for each course. Serious adverse events will be analyzed similarly.

Analysis population: All eligible patients who received at least one cycle of chemotherapy were evaluable for toxicity.

Groups in this outcome

Treatment (Chemotherapy and Enzyme Inhibitor Therapy)

Patients receive cyclophosphamide IV and vincristine sulfate IV on day 1, etoposide IV on days 1-3 or PO QD on days 2-3, and prednisone PO QD on days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR, per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation. prednisone: Given PO cyclophosphamide: Given IV etoposide: Given PO or IV vincristine sulfate: Given IV pralatrexate: Given IV laboratory biomarker analysis: Correlative studies comparative genomic hybridization: Correlative studies gene expression analysis: Correlative studies nucleic acid sequencing: Correlative studies mutation analysis: Correlative studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)	33

Reported measurements

Grade 3-4 anaemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)	27	Not reported	Not reported	Not reported	Not reported

Grade 3-4 thrombocoytopenia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)	12	Not reported	Not reported	Not reported	Not reported

Grade 3-4 febrile neutropenia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)	18	Not reported	Not reported	Not reported	Not reported

Grade 3-4 mucositis

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)	18	Not reported	Not reported	Not reported	Not reported

Grade 3-4 sepsis

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)	15	Not reported	Not reported	Not reported	Not reported

Grade 3-4 increased creatinine

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)	12	Not reported	Not reported	Not reported	Not reported

Grade 3-4 liver transaminases

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)	12	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
27
title
Grade 3-4 anaemia
categories
measurements
group Id
OG000
value
12
title
Grade 3-4 thrombocoytopenia
categories
measurements
group Id
OG000
value
18
title
Grade 3-4 febrile neutropenia
categories
measurements
group Id
OG000
value
18
title
Grade 3-4 mucositis
categories
measurements
group Id
OG000
value
15
title
Grade 3-4 sepsis
categories
measurements
group Id
OG000
value
12
title
Grade 3-4 increased creatinine
categories
measurements
group Id
OG000
value
12
title
Grade 3-4 liver transaminases

denoms

counts
group Id
OG000
value
33
units
Participants

description

groups

description
Patients receive cyclophosphamide IV and vincristine sulfate IV on day 1, etoposide IV on days 1-3 or PO QD on days 2-3, and prednisone PO QD on days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR, per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation. prednisone: Given PO cyclophosphamide: Given IV etoposide: Given PO or IV vincristine sulfate: Given IV pralatrexate: Given IV laboratory biomarker analysis: Correlative studies comparative genomic hybridization: Correlative studies gene expression analysis: Correlative studies nucleic acid sequencing: Correlative studies mutation analysis: Correlative studies
id
OG000
title
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)

param Type

NUMBER

population Description

All eligible patients who received at least one cycle of chemotherapy were evaluable for toxicity.

reporting Status

POSTED

time Frame

22 months

title

To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events

type

SECONDARY

unit Of Measure

percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice